BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0998-00-0600-2054U

    MDR report key: 1653394 · Received March 30, 2010

    Report

    Report Number
    2221819-2010-00007
    Event Type
    Malfunction
    Date Received
    March 30, 2010
    Date of Event
    January 25, 2010
    Report Date
    January 26, 2010
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) SENT PHOTOGRAPHS TO MINDRAY THAT SHOW THAT THE PLASTIC HINGE BARREL BROKE ON THE MOUNT IN QUESTION, WHICH IS FIVE YRS OLD. THIS MOUNTING ASSEMBLY IS CURRENTLY MFG BY (B)(4) FOR MINDRAY DS USA, INC (FORMERLY DATASCOPE PATIENT MONITORING AND PRIOR TO THAT, DATASCOPE CORP.). THE MOUNTING ASSEMBLY THAT FAILED AT (B)(6) WAS MFG FOR DATASCOPE CORP. BY (B)(4). THE CHANGE IN SUPPLIER (B)(4) WAS MADE FOR BUSINESS RELATED REASONS. DURING THE DESIGN TRANSFER PROCESS, AN IMPROVEMENT WAS MADE TO THE DESIGN OF THE LATCH. THE PLASTIC THAT HOLDS THE PIN TO THE MOUNT WAS STRENGTHENED. MOUNTS WITH THE IMPROVED LATCH DESIGN ARE ON ORDER, AND THE FIRST SHIPMENT IS EXPECTED TO BE RECEIVED SHORTLY. (B)(4).

    Description of Event or Problem · 1

    WE RECEIVED AN INQUIRY FROM (B)(6) RELATED TO THE FOLLOWING EVENT: "BASE PLATE CLAMP ON ROLLING STAND THAT SECURES MONITOR TO IT HAS BROKEN OFF. MONITOR THEREFORE PROJECTED OFF STAND AND SMASHED ONTO FLOOR NARROWLY MISSING STAFF AND PTS. RESULTS BEING THAT THE DISPLAY AND CASING DAMAGED OTHER INTERNAL ISSUES YET KNOWN. UNIT REMOVED FROM WARD AREA. BASE PLATE RETAINED WITHIN EBME DEPT AND THE REPAIR PROCESS STARTED FOR THE MONITOR." NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0998-00-0600-2054U TRIO MHX MINDRAY DS USA, INC. TRIO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK